Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Trial end date: 2018-01-02
• Target enrollment: 0
• Participant gender: All

Summary

Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and scheduling regimens, and with varying measures of success. The hypothesis of the study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during treatment for ALL on the Total XVI protocol (or for those being treated "as per TOTXVI protocol"), as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Gabapentin; Vincristine

Criteria

Inclusion Criteria:

• Participant is enrolled on Total XVI or who are being treated "as per TOTXVI protocol"

• Participant is 1 year of age or older

• Participant has symptoms of NP/PN with onset no more than 7 days after one of the following vincristine doses ± 3 days: protocol week 1, week 2 (induction), week 7 (reinduction I), or week 17 (reinduction II).

• Patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the Total XVI protocol (or for those being treated "as per TOTXVI" protocol) while on study drug (i.e. no known dosage reductions or planned missed doses).

Participant is able and willing to take oral medications.

Exclusion Criteria:

• Previous participation in this study

• Participant is receiving gabapentin for another indication at the time of diagnosis of NP/PN or has received gabapentin previously.

• Pregnancy. Female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. Male patients with reproductive potential will be counseled not to procreate during the study.

• Impaired renal function: decreased eGFR (<60ml/min/1.73m^2 as estimated by the revised Schwartz equation)

• Participant has allergy or other contraindication for either morphine or gabapentin therapy.

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.